GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
FDA Recall Z-1247-2022 · Posted None
Recalling FirmMedacta Usa Inc
Recall StatusTerminated
Product CodeLXH
Date Initiated2022-04-13
Date Terminated2023-10-23
Product Quantity50 units
Reason for Recall
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Firm Action
The recalling firm emailed their sales agents on 4/13/2022 to notify them the implants were associated with a recall and must be returned immediately to the recalling firm. It also said that replacements are currently on order and will be overnighted to them once they are available. A copy of the Field Safety Notice from the manufacturer was forwarded to the sales agents. The Notice informed them the three affected lots have been assembled following an incorrect packing list, resulting in a size 2 trial baseplate being inserted in a size 1 instrument set, and that all the other devices included in the packing list and instrument set are correct.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.